Partnering for Student Wellness

Mental Health Clinical Trial

— PSW  

Official title:

Patient Centered Enhancements in School Behavioral Health: A Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03901274
• Other study ID #: Pro00085951
• Status: Completed
• Phase: N/A
• Start date: September 10, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2024
• Source: University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate whether the evidence-based Clinical Services Supports (CSS) framework paired with an evidence-based Patient Centered Enhancement (PCE) compared to CSS alone will improve middle school students' social, emotional/behavioral, and academic functioning.

Description:

The mental health needs of children and youth are well-documented as an under-addressed and significant public health need in the United States. A number of barriers prevent children, youth, and families from accessing behavioral health services in standard clinic settings, including lack of sufficient transportation, cost, and stigma related to receiving services. School behavioral health (SBH) programs-in which community mental health providers join school teams to better address the social, emotional/behavioral, and academic needs of students-are growing in the United States because of their ability to reach youth who need, but may not otherwise receive, services. However, these efforts are limited by a lack of patient and stakeholder engagement. This has commonly resulted in SBH programs not being implemented, implemented inconsistently, or underutilized. The study will compare an evidence-based Patient-Centered Enhancements (PCE) intervention added to an evidence-based framework termed Clinical Services Supports (CSS) in a three-year intervention for students in middle schools. Investigators predict the addition of the PCE intervention will improve school climate and enhance SBH services, resulting in significantly improved social, emotional/behavioral, and academic outcomes in students. The study has three aims:

1. Investigators will evaluate the extent to which PCE increases the number of students and families receiving school behavioral health services and expressing satisfaction with services received.

2. Investigators will evaluate the impact of PCE on students' social, emotional/behavioral, and academic outcomes throughout the course of the intervention period (sixth through eighth grade).

3. Investigators will evaluate the follow-up effects of PCE on social, emotional/behavioral, and academic outcomes and risk behaviors in a sample of students followed into high school.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1279
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Middle school student

• Receives school-based behavioral health services

• Parent of a middle school student

• Parent of a student receiving school-based behavioral health services

• Enrolled in a participating school

Exclusion Criteria:

• Not a middle school student

• Not receiving school-based behavioral health services

• Not a parent of a middle school student

• Does not have a child receiving school-based behavioral health services

• Not enrolled in a participating school

Related Conditions & MeSH terms

• Mental Health

Intervention

Behavioral:
• Clinical Services Support
The CSS framework packages together evidence-based practices of family engagement, modular evidence-based practice, quality assurance, and implementation support. Depending on their time of enrollment, participants can be involved in this condition for one to three years. They will be asked to complete assessments during their therapy sessions periodically throughout the trial.
• Patient Centered Enhancements
The two PCEs are: enhancing mental health literacy and stigma reduction, and improving family-school-mental health partnerships. Depending on their time of enrollment, participants can be involved in this condition for one to three years. They will be asked to complete assessments during their therapy sessions periodically throughout the trial.

Locations

Country	Name	City	State
United States	University of Maryland, Baltimore	Baltimore	Maryland
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of South Carolina	Columbia	South Carolina

Sponsors (4)

Lead Sponsor	Collaborator
University of South Carolina	Medical University of South Carolina, Patient-Centered Outcomes Research Institute, University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

References & Publications (10)

Abrishami, G.F. & Warren, J.S. (2013). Therapeutic alliance and outcomes in children and adolescents served in a community mental health system. Journal of Child & Adolescent Behavior, 1(2), 1-7.

Brener ND, Collins JL, Kann L, Warren CW, Williams BI. Reliability of the Youth Risk Behavior Survey Questionnaire. Am J Epidemiol. 1995 Mar 15;141(6):575-80. doi: 10.1093/oxfordjournals.aje.a117473. — View Citation

Chorpita BF, Reise S, Weisz JR, Grubbs K, Becker KD, Krull JL; Research Network on Youth Mental Health. Evaluation of the Brief Problem Checklist: child and caregiver interviews to measure clinical progress. J Consult Clin Psychol. 2010 Aug;78(4):526-36. doi: 10.1037/a0019602. — View Citation

Connors, E.H., Stephan, S.H., Lever, N., Ereshefsky, S., Mosby, A., & Bohnenkamp, J. (2016). A national initiative to advance school mental health performance measurement in the US. Advances in School Mental Health Promotion, 9(1), 50-69.

Haine-Schlagel R, Roesch SC, Trask EV, Fawley-King K, Ganger WC, Aarons GA. The Parent Participation Engagement Measure (PPEM): Reliability and Validity in Child and Adolescent Community Mental Health Services. Adm Policy Ment Health. 2016 Sep;43(5):813-823. doi: 10.1007/s10488-015-0698-x. — View Citation

Kutcher S, Wei Y, Morgan C. Successful Application of a Canadian Mental Health Curriculum Resource by Usual Classroom Teachers in Significantly and Sustainably Improving Student Mental Health Literacy. Can J Psychiatry. 2015 Dec;60(12):580-6. doi: 10.1177/070674371506001209. — View Citation

Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207. doi: 10.1016/0149-7189(79)90094-6. No abstract available. — View Citation

Mcluckie A, Kutcher S, Wei Y, Weaver C. Sustained improvements in students' mental health literacy with use of a mental health curriculum in Canadian schools. BMC Psychiatry. 2014 Dec 31;14:379. doi: 10.1186/s12888-014-0379-4. — View Citation

Price CS, Spence SH, Sheffield J, Donovan C. The development and psychometric properties of a measure of social and adaptive functioning for children and adolescents. J Clin Child Adolesc Psychol. 2002 Mar;31(1):111-22. doi: 10.1207/S15374424JCCP3101_13. — View Citation

Weist, M.D., Sander, M.A., Walrath, C., Link, B., Nabors, L., Adelsheim, S., ... & Carrillo, K. (2005). Developing principles for best practice in expanded school mental health. Journal of Youth and Adolescence, 34(1), 7-13.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in academic grades	Quarterly academic grades for ELA, math, social studies, and science	Baseline (summer before intervention), mid-treatment (annually for three years of intervention), post-treatment (one year after intervention)
Primary	Change in academic attendance rates	Quarterly attendance (tardy and absence); including date, type of attendance (excused, unexcused), and reason for absence or tardy (if applicable)	Baseline (summer before intervention), mid-treatment (annually for three years of intervention), post-treatment (one year after intervention)
Primary	Change in discipline rates	Quarterly discipline; including date, reason for office discipline referral, consequence as a result of the referral, and length of the consequence (if applicable)	Baseline (summer before intervention), mid-treatment (annually for three years of intervention), post-treatment (one year after intervention)
Primary	Change in perceptions of school climate	School Climate Survey (SCS): a free, online climate survey from the US Department of Education. The SCS is a 73-item questionnaire for students and an 83-item questionnaire for school staff on a 4 point scale ranging from 1 "Strongly Agree" to 4 "Strongly Disagree".	Baseline (summer before intervention), mid-treatment (annually for three years of intervention), post-treatment (one year after intervention)
Primary	Change in access to services	Number of sessions conducted by the clinician in categories of assessment; individual, group, and family therapy; case management; and teacher consultation	Baseline (summer before intervention), mid-treatment (annually for three years of intervention)
Primary	Change in client satisfaction with services	Client Satisfaction Questionnaire-8 (CSQ-8): 8-item measure for youth 11 and older and adults to assess individual's satisfaction with counseling services. The items range from 1 "Poor" to 4 "Excellent".	Mid-treatment (through three years of intervention, an average of 3 per year)
Primary	Change in social functioning of students receiving services	Child and Adolescent Social and Adaptive Functioning Scale (CASAFS): 24-item measure on school performance, peer relations, family relations, and home duties/self-care. The items range from 1 "Never" to 4 "Always". For some items, a 5th option "Does not apply to me" is available.	Baseline (intake), mid-treatment (through three years of intervention, an average of 3 per year), post-treatment (one year after intervention)
Primary	Change in emotional/behavioral functioning of students receiving services	Brief Problem Checklist: 12-item questionnaire measuring externalizing and internalizing problems. The Brief Problem Checklist ranges from 1 "Not True" to 3 "Very True".	Baseline (intake), mid-treatment (through three years of intervention, an average of 3 per year), post-treatment (one year after intervention)
Primary	Determine emergent risk behavior of students receiving services	Youth Risk Behavior Survey (YRBS): developed by the Centers for Disease Control and Prevention. The YRBS is a 58 item scale. The items in the survey do not have one consistent scale.; Example scales are: 1 "Never" to 5 "Always"; 1 "0 times" to 5 "6 or more times"; 1 "0 days" to 7 "All 30 days"; 1 "0 days" to 5 "6 or more days"; 1 "0 times" to 8 "12 or more times"; 1 "Yes" to 2 "No"; 1 "0 times" to 7 "100 or more times"; 1 "0 times" to 6 "40 or more times"; 1 "0 times" to 3 "2 or more times"; 1 "I did not (insert activity; e.g., drive a car, drink alcohol, have intercourse) during the past 30 days" to 6 "6 or more times"	Post-treatment (one year after intervention)
Secondary	Change in mental health knowledge and perceived stigma	The Guide Curriculum Assessment (GSA): utilizing two subscales: Mental Health Knowledge (30 items; 1 "True" to 3 "Don't know"), Perceived Stigma (12 items; 1 "Strongly Agree" to 7 "Strongly Disagree")	Baseline (intake), mid-treatment (through three years of intervention, an average of 3 per year)
Secondary	Change in family-school-community partnerships	SBH Quality Assessment Tool (SBHQAT) is a tool to assess the overall standard of services and supports provided in a school. The SBHQAT is a 5-item assessment with items ranging from 1 "Not in place" to 6 "Fully in place"	Mid-treatment (beginning and end of the school year for three years of intervention)
Secondary	Change in family-school-community partnerships	Therapeutic Alliance Scale for Children-revised (TASC) is a twelve item scale from 1 "Not true" to 4 "Very much true" measuring the client-therapist relationship.	Baseline (intake), mid-treatment (through three years of intervention, an average of 3 per year)
Secondary	Change in family-school-community partnerships	Parent Participation Engagement Measure is a 5 item measure with items ranging from 0 "Not applicable" to 5 "Very much".	Baseline (intake), mid-treatment (through three years of intervention, an average of 3 per year)

External Links

•   Free, online school climate survey from the US Department of Education